DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-7 and 12-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent 4,322,201 to Archibald in view of US Pre-Grant Publication 2007/0062251 to Anex, U.S. Patent 5,791,344 to Schulman et al. (Schulman) and U.S. Patent 5,575,310 to Kamen (Kamen).
Regarding claim 1, Archibald teaches a method of operating an infusion system (10, 12) comprising a controller (72), a pump (10), a pump chamber (34) and a pump actuator assembly (70), the method comprising flowing fluid from a reservoir (12) to the pump chamber, sending a signal (see Fig. 1) from the controller to the pump actuator assembly to operate, and compressing the fluid in the pump chamber with the pump actuator assembly (via 46 and 86). Archibald does not teach the continuous analyte sensor or the volume sensor and does not explicitly state that feedback control is performed. Anex discloses a system for at least partial closed-loop control of a medical condition (paragraph 24), the system comprising: at least one medical fluid pump (103) for infusing fluid into a user, the at least one medical fluid pump comprising a sensor (volumetric flow sensor, [0029] for determining the volume of fluid infused into the user by the at least one medical fluid pump, wherein the sensor is located a path to the user; at least one continuous analyte monitor (analyte monitoring, [0050]); and a controller (closed loop controller, 105), the controller in communication with the medical fluid pump and the at least one continuous analyte monitor [0050], the controller comprising a processor (microprocessor, [0054]), the processor comprising instructions for delivery of medical fluid based at least on data received from the at least one continuous analyte monitor [0054]. Furthermore, to any extent which Anex does not motivate one of ordinary skill in the art to control the infusion based on the sensed analyte level, Schulman teaches another analyte monitoring system generally, and particularly teaches that such analyte sensing is performed specifically to allow a corrective action to be taken by e.g. infusion of insulin (col. 1, ln. 60 through col. 2 ln. 9). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to add a continuous analyte sensor as taught by Anex to the pump of Archibald so as to allow infusion management responsive to patient status as indicated by the sensed analyte level as taught by Schulman. Archibald and Anex also do not teach an acoustic volume sensor, though notably Anex teaches that in a fixed volume system, a position signal is tantamount to a volume signal (e.g. paragraph 42). Kamen discloses an acoustic volume sensor for determining the volume of fluid infused into the user by the at least one medical fluid pump (Figures 5-7 and Column 6, line 62-Column 7, line 20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide an acoustic volume sensor for determining the volume of the fluid infused into the user by the at least one medical fluid pump for optimal fluid control (abstract)). Alternatively, the examiner notes that Archbald, Anex and Schulman teach a system which differs from the claimed invention only in the use of an acoustic volume sensor as opposed to another sensor. Kamen shows that such a sensor is known for the common application at issue. Accordingly, the use of an acoustic volume sensor is considered to constitute the mere substitution of one known volume sensor for another, according to the well understood methods of operation and construction evinced by these references considered together. Regarding the location of the measurement valve, Kamen teaches a measurement valve (Valve B) in fluid communication between the fluid source and the volume sensor. In the combination, the pump and fluid source of Archibald would take the place of the fluid source and the measurement valve would therefore be located between the volume sensor and the patient. Finally, the examiner notes that the measurement process of Kamen involves the measurement valve (valve B) being actively controlled by signals (col. 11, ln. 17-24) which is tantamount to sending a measurement signal and actuating the measurement valve.
Regarding claims 3 and 4, Archibald teaches an inlet valve (55) between the pump and the reservoir. Archibald further teaches providing at least a mechanical signal thereto prior to a similar mechanical signal being sent to the pump actuator assembly. The examiner notes that the operation of pump (10) is cyclical, and any signal sent during one cycle is prior to any signal sent in a subsequent cycle.
Regarding claims 5-7, as noted above, Anex teaches the use of a continuous analyte sensor (paragraphs 50, 54) and at least implicitly teaches sensing over a period of time (including predetermined intervals) and sending a signal to the controller. The examiner notes that the second analyte sensor is not claimed simultaneously to the first. That is, a replacement analyte sensor would qualify as a second analyte sensor which would be used identically to the first. As such, since it has been held that the mere duplication of parts does not constitute evidence of non-obviousness (MPEP 2144.04 VI.), the examiner holds that one of ordinary skill in the art would have found it obvious before the effective filing date of the application to duplicate, either simultaneously or serially, the analyte sensor of Anex in the pump of Archibald in order to obtain analyte members either redundantly or subsequent to sensor failure.
Regarding claims 12 and 13, Anex discloses that the continuous analyte monitor is a glucose monitor (glucose, [0045]).
Regarding claims 14-17, Archibald teaches a volume sensor valve (58) between the volume sensor of Kamen and the pump (at 34), and generation of sufficient pressure (at 34 in addition to the mechanical pressure at 80) to open the volume sensor valve.
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Archibald in view of Anex, Schulman and Kamen as applied to claim 1 above, and further in view of US Pre-Grant Publication 2009/0192380 to Shariati et al. (Shariati).
Regarding claim 8, the previously applied references do not teach disregarding signals if differing by greater than a predetermined amount. Shariati teaches another sensing system generally, and particularly teaches that analyte levels determined thereby are subjected to a low-pass filter (which filters out changes above a threshold, see paragraph 513) in order to reduce noise and obtain more accurate measurements. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a low-pass filter as taught by Shariati with the signals from the analyte sensor of Anex in the system of Archibald in order to obtain more accurate measurements.
Claims 9 and 10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Archibald in view of Anex, Schulman and Kamen, further in view of U.S. Patent Pub. No. 2005/0203360 to Brauker et al.
Regarding claim 9, the previously applied references teach the limitations of claim 1 from which claims 9 and 10 depend, but do not teach blood oxygen or temperature sensing. Brauker teaches monitoring blood oxygen (passage 220) and temperature (passage 0230) at a sensor which is part of the infusion system. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Archibald with the sensors of Brauker with the motivation of using components already well known in the art (as evidenced by Brauker) in order to effectively deliver medicament to a patient in as ideal conditions as possible.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Archibald in view of Anex, Schulman and Kamen as applied to claim 1 above, and further in view of U.S. Patent 4,551,133 to Zegers de Beyl et al. (Zegers de Beyl hereinafter).
Regarding claim 11, the previously applied references teach the limitations of claim 1, but do not teach the use of heart rate sensing. Zegers de Beyl teaches another infusion system generally, and particularly teaches infusing responsive to heart rate (col. 8, ln. 57). Zegers de Beyl teaches that this system allows cessation of infusion and notification of medical personnel in the case of a patient’s deteriorated condition (col. 2, ln. 3-18). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to monitor heart rate and responsively control infusion as taught by Zegers de Beyl in the pump of Archibald in order to appropriately cease infusion.
Response to Arguments
Applicant’s arguments, see page 6, filed 26 January 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered but are not persuasive.
With respect to applicant’s argument that the combination fails to teach the flowing of fluid from the reservoir to the pump, the examiner notes that this is present in the upstream side of the pump of Archibald as discussed above. As the volume sensor thereof is downstream of the pump sections, so too would be the measurement valve and patient when the sensor of Kamen is substituted into the pump of Archibald. This indicates that the claimed arrangement arises naturally from the straightforward substitution of one known volume sensor for another as held in the rejection. At the same time, the combination does not alter the upstream side of the pump of Archibald, so applicant’s argument regarding the flow of fluid from the reservoir to the pump does not address the actual position taken by the examiner regarding the combination.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3746 20 February 2026